Offerte di lavoro in remoto e a domicilio a US, Indianapolis IN ∙ Pagina 1

In this role individuals will support complaint handling and associated activities for devices, drug/device combination products and Connected Care products as needed.

Key Objectives / Deliverables:

• Review and approve complaint investigations for devices, drug/device combination products, and Connected Care devices and Consumer Electronic Products.  

• Initiate and support Trend analysis, Root Cause Investigations, response to Regulatory authority requests, or other technical investigations, as applicable  

• Perform and document quarterly trend analysis and investigations on product and process performance  

• Compile and document ad-hoc reports, as needed  

• Perform annual evaluation of occurrence/pHarm rankings in support of the post launch risk management process  

• Understand the devices (including connected care devices) and drug/device combination products to support investigations.   

• Support activities associated with device safety surveillance for both devices and drug/device combination products  

• Collaborate, participate in projects, and provide customer service for stakeholders including, but not limited to, Regional Centers, OUS Affiliates, and Global Patient Safety.

• Review/write/approve GMP documents including SOPs, global training, global procedures/non-method procedures, technical reports, and process level procedures and training, as applicable  

• Support continuous improvement projects and new launches as needed  

• Participate in project work that requires substantial technical knowledge and continuous improvement skills  

• Participate in Failure Modes and Effects Analysis (FMEA), as applicable  

• Utilize non-routine software tools or business systems to gather data and provide metrics on device complaint issues or complaint process efficiency  

• Ensure compliance with Medical Device Reporting (MDR) and other regulatory reporting requirements.  

• Support Clinical Trial complaint management by establishing processes for each unique trial, ensuring investigations are completed and approved, performing investigations when needed, and reporting metrics.     

• Assess impact to local and global complaint investigation documents/processes when global documents or systems change and in support of development projects and project launches. Perform gap assessments on local documents when global documents are updated.  

• Network within and outside of department to identify and implement opportunities for improvement and/or transfer of complaint handling best practices to other business partners.  

• Drive product and process improvements through data obtained from complaint trending activities.

Education Requirements:

• Bachelor’s degree required. Degree in Engineering, Medical or Life Sciences preferred. 

Minimum Requirements:

• Minimum of 3 years industry experience in areas which may include Quality, MS&T, LRL, Development or Manufacturing/Packaging 

• Technical knowledge in design, manufacturing or validation; preferably devices 

• Technical knowledge of complaint handling and/or quality systems; preferably devices 

• Knowledge of regulatory requirements (e.g., cGMP, 21 CFR 820, ISO13485, Canadian MDR) 

• Strong computer literacy in Outlook and Microsoft  

• Basic knowledge in statistics and its applications 

• Ability to compile data and metrics in reports understandable by management and business partners 

• Attention to detail; self-management; problem solving; mentoring